"This is the best use of my time to remain current with what is going on in the industry."
Medical Informatics (Japan Society for Medical Informatics) article on use of eSRA to assess the requirements of the Japan MHLW's "Guideline on security management for medical information systems."
Several members of the eClinical Forum's Regulatory Advisory Group have published an article in Applied Clinical Trials on "When should audit trail begin?" It is a discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.
We welcome feedback! Please send to: REG@eclinicalforum.org
eCF Webinar on RBQM, ATRA, and Fit-for-Purpose Data
Log in to your eCF website account to see more:
RBQM is now a requirement under ICH E6(R3). But how does it fit with other data review activities?
The webinar is available to all our members. Date and Time: Wednesday, 25 February 2026, 14:00 UTC.
eCF Spring 2026 Workshops Announced!
We are happy to announce our Spring workshops!
Europe/Hybrid: Hosted by Servier outside of Paris on April 14-16 (this will be livestreamed as well)
Americas: Hosted by YPrime outside of Philadelphia, PA on April 28-30
Asia: Hosted by Novartis in Tokyo, Japan on April 2-3